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Docusate Potassium
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C20H37KO7S 460.67

Butanedioic acid, sulfo-, 1,4-bis(2-ethylhexyl) ester, potassium salt.
Potassium 1,4-bis(2-ethylhexyl) sulfosuccinate [7491-09-0].
» Docusate Potassium contains not less than 95.0 percent and not more than 100.5 percent of C20H37KO7S, calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
USP Reference standards 11 USP Docusate Potassium RS. USP Bis(2-ethylhexyl)maleate RS.
Identification—
A: Place a small piece of it on a salt plate, add 1 drop of acetone, and promptly cover with another salt plate. Rub the plates together to dissolve the specimen, slide the plates apart, and allow the acetone to evaporate: the IR absorption spectrum of the film so obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Docusate Potassium RS.
B: It responds to the flame test for Potassium 191.
Loss on drying 731 Dry it in a glass container at 105 for 4 hours: it loses not more than 3.0% of its weight.
Residue on ignition 281: between 18.0% and 20.0%, calculated on the dried basis.
Heavy metals 231 It meets the requirements of the test for Heavy metals under Docusate Sodium.
Limit of bis(2-ethylhexyl) maleate Place 12.5 g of Docusate Potassium, previously dried and accurately weighed, in a 100-mL volumetric flask. Pipet 20 mL of pH 10 alkaline borate buffer (see under Solutions in the section Reagents, Indicators, and Solutions) into the flask, and add about 70 mL of alcohol. Swirl the flask and contents, with gentle warming if necessary, until the solid dissolves. Adjust the reaction dropwise, if necessary, with 1 N sodium hydroxide to a pH of 10. Add alcohol to volume, and proceed as directed in the test for Bis(2-ethylhexyl)maleate under Docusate Sodium, beginning with “Transfer a portion of this solution to a polarographic cell.” The diffusion current for the test solution of Docusate Potassium is not greater than one-half the diffusion current of the solution containing the added bis(2-ethylhexyl)maleate [not more than 0.4% of bis(2-ethylhexyl)maleate].
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay—
Tetra-n-butylammonium iodide solution, and Salt solution— Prepare as directed in the Assay under Docusate Sodium.
Procedure— Dissolve about 100 mg of Docusate Potassium, accurately weighed, in 50 mL of chloroform in a glass-stoppered, 250-mL conical flask. Proceed as directed in the Assay under Docusate Sodium, beginning with “Add 50 mL of Salt solution.” Each mL of Tetra-n-butylammonium iodide solution is equivalent to 3.118 mg of C20H37KO7S.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 748
Pharmacopeial Forum : Volume No. 31(3) Page 753
Phone Number : 1-301-816-8251